In an open statement, the Advanced Medical Technology Association (AdvaMed), Washington, DC, has addressed the FDA’s final rule establishing a unique device identification (UDI) system for medical devices.
“While we are still reviewing all the details of the final rule, AdvaMed commends FDA for addressing many of the concerns industry raised in the proposed rule,” Janet Trunzo, AdvaMed’s senior executive VP, technology and regulatory affairs, says in the statement.
“We have long supported a UDI system for medical devices that, if appropriately implemented, holds the promise of more accurate and useful postmarket surveillance and more rapid medical technology improvements. And this rule is a good step toward achieving that goal.”
In particular, Trunzo noted:
- the FDA recognized the “difficulty and limited benefit of direct marking of implants.” The final rule eliminates the requirement.
- an update, requiring that multiple single-use devices within multipacks only need the UDI on the multipack and not the individual device.
- the FDA’s acknowledgment that implementation of the system is dependent on current inventories being depleted. In response, the FDA will allow an additional 3 years for inventories to be depleted.
To read the full statement, click here.